G. Pilot and Feasibility Program Management of the pilot and feasibility program. The Vanderbilt CDTR proposes to support Pilot and Feasibility (P&F) funding for type 11 translation research in diabetes through it's Administrative Core. These funds are used for: 1) new investigators; 2) established investigators from other fields who bring their research expertise to diabetes; or 3) investigators in diabetes research who wish to test a new idea. This funding mechanism provides support will allow an investigator the opportunity to develop the pilot data that will serve as the basis for obtaining independent research support through conventional external, peer-reviewed granting mechanisms. Two P&F studies will be supported to a maximum of one year and it is not intended for large undertakings by established investigators for which it would be appropriate to submit separate research grant applications nor to support or supplement ongoing research. Currently applicants must be a member of the VUMC or Meharry faculty (Instructor or above) to submit a P&F proposal, and they must meet the NIH Eligibility Guidelines for P&F support (see Regional Center for expansion of applicant pool). Since eligibility for P&F studies vary among institutions, some recent examples may be helpful. 1. A study proposed by a young investigator with an interest in a career in research in diabetes or its management, before his/her career has developed to the point of being able to obtain individual grant support. 2. A study proposed by an established investigator who has experience in areas other than diabetes and who wants to test a diabetes-related hypothesis that is relevant to the CDTR mission. 3. A study proposed by an established investigator in diabetes who wants to work in an entirely new research area (i.e., that is not an extension of ongoing funded research). In the fall of each year, all faculty members at Vanderbilt University and Meharry Medical College are informed of the CDTR P&F program by a variety of electronic announcements (email, posting of funding opportunities newsletters, etc.). This communication will be sent with the DRTC mailing that also requests proposals for P&F funding. Often potential applicants discuss their proposal and eligibility with the P&F director before submitting a proposal for the January deadline. G1. Director of P&F Program. Dr. Elasy, Center Director, has been a member of the Vanderbilt DRTC P&F review committee for the last 4 years and is ideally suited to continue his collaboration with the Vanderbilt DRTC to shepherd the P&F program of the CDTR . In addition, he was a recipient of a Diabetes Center P&F in 1999. Dr. Elasy brings considerable expertise in the evaluation of research proposals through his service on external grant review committees, including the NIDDK R18/R34 mechanism. He is also a member of the Vanderbilt CTSA scientific review committee which evaluates funding requests through the CTSA. The P&F Director's specific responsibilities are to: 1) solicit proposals from the Vanderbilt and Meharry faculty; 2) work in conjunction with the Pilot and Feasibility Review Committee to assign reviewers for each proposal; 3) chair the committee that evaluates the written critiques and conveys funding recommendations to the CDTR Scientific Committee; 4) provide review summaries to each applicant that outlines the strengths and weaknesses of the proposal and, if pertinent, provides information about other funding options; and 5) organize the P&F symposia that provides the opportunity for each funded investigator to describe the research supported by the program. G2. P&F Review Process. Each research proposal is submitted electronically (PDF file) in the NIH format and assigned to reviewers by the P&F Review Committee, which is comprised of Drs. Elasy (Chair), Russell Rothman, Elizabeth Weiner, Shari Barkin and David Schlundt. The members of this committee are active members of the existing Prevention and Control core of the DRTC and have considerable perspective on the P&F program. The members of the review committee also bring substantial research expertise that encompasses the range of research within the CDTR. The CDTR Administrative Core, Deborah Brown, will provide logistical and administrative support for the P&F program (communicating with reviewers, copying, etc.). Four reviewers with appropriate expertise are assigned for each proposal, including two external to Vanderbilt and Meharry, with an honorarium provided to the external reviewers. The research experience of the P&F Review Committee is particularly useful in identifying both internal and external reviewers with appropriate scientific expertise. Faculty members from the applicant's department are excluded from review consideration to preclude a conflict of interest. Even though identifying and arranging for two external and two internal reviewers for each proposal requires much effort (we currently receive ~ 5 type 11 translation proposals each year), we strongly believe that this approach ensures that each proposal receives a thorough review based on appropriate scientific expertise. The reviewers are sent the applicant's proposal and biosketch electronically and are asked to rate the grant using the NIH scoring system. The written critiques, including comments on eligibility for P&F funding and the budget, will be returned to the CDTR office. The grants are then ranked in regards to score and the top 50% of proposals are reviewed at a meeting of the P&F Review Committee. We invite one internal reviewer of each discussed proposal to attend and to present the proposal to the P&F Review Committee (similar to a NIH Study Section). The discussion of each proposal centers on the strengths of the proposal, the fairness and integration of the reviews, the relevance of the subject matter, the eligibility and potential for future funding for the Pl, and the likelihood that funding will encourage a commitment to diabetes research. After each proposal has been fully considered and the internal reviewer departs, the Chair (Dr. Elasy) will call for a vote regarding approval, and priorities are assigned in accordance with standard NIH Study Section principles and practices. The scientific scores are then conveyed to the CDTR Committee for a final funding decision. While the reviewers' scores are an important factor in the final score submitted by the P&F Review Committee, other critical factors are the investigator's potential for securing independent research funding and how the subject of the grant fits into the overall CDTR research program. Thus, the final decision by the Scientific Committee allows for strategic decisions regarding both the investigator and type of research supported. Each of the funded investigators is also requested to participate in annual DRTC Diabetes Research Symposium (see Enrichment section of proposal) and to present a poster summarizing his/her studies. G3. Importance of P&F support - Augmenting Funding The P&F mechanism has been an essential method for attracting new investigators to type 11 translation research. Drs Elasy (1999), Rothman (2005), Barkin (2007), Osborn (2008) and Mulvaney (2008) are all past P&F recipients and now are key members of our center. We are committed to increasing the availability of resources to support this important service of our Center. After reviewing the scores received by applicants over the past 5 years who submitted applications that would be deemed translation in nature, we feel that the current # of grants (2 per year) is likely adequate to support the most meritorious of our applicants. The NIH allows a maximum of $50,000/year and requires that 2 applications are funded each year. We do not feel that $25,000 per application is likely to be sufficient based on our own experience. To that end, we will augment support in two ways. Dr. Elasy will commit an additional $10,000 per P&F award over the upcoming funding cycle. In addition, we have made arrangements for all applicants to seek supplementary funds through the CTSA mechanism (see Bernard, CTSA Director, letter of support) on which Dr. Elasy serves as part of the scientific review committee. This will increase the guaranteed funds to 35,000/year and permit a significant increase in that base depending on the specific needs of that project.